Status:
UNKNOWN
Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal...
Detailed Description
Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratecto...
Eligibility Criteria
Inclusion
- The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
- At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
- Expected to use intraocular lens power in -10.0D\~+30.0D
- Willing and able to comply with scheduled visits and other study procedures.
- The need to decrease the dependence of glasses
- Signing an informed consent form
Exclusion
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- The density of corneal endothelial cells is lower than 2000/mm2
- The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
- The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
- Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)
- Occurrence of irregular corneal astigmatism that affects postoperative vision
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye
- Pregnant, lactation or planning to become pregnant in the near future
- Any surgical contraindications
- Uncontrolled systemic or ocular disease
- Use of any systemic or topical drug known to interfere with visual performance
- Other ocular surgery at the time of the cataract extraction
- Traumatic cataract or congenital bilateral cataract in the operated eye
- Getting used to reading with glasses
- High requirements for visual functions in patients' career or daily life
- Professional drivers or frequent outdoor workers at night
- A medical history of photophobia
- Amblyopia
- Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky
- Unsupervised or unable to comply with scheduled visits
- The contralateral eye was judged to lose visual function
- Other situations where the researcher judges that the patient is not suitable for inclusion
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04522427
Start Date
September 1 2020
End Date
August 31 2022
Last Update
August 21 2020
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031